Solid CancersPhase 1NCT01301716
A Study of the Safety and Pharmacology of GDC-0980 in Combination With Either Paclitaxel and Carboplatin (With or Without Bevacizumab) or Pemetrexed and Cisplatin in Patients With Solid Tumors
A Phase 1 study testing GDC-0980, bevacizumab and carboplatin in people with Solid Cancers, run by Genentech, Inc. at 5 sites in 2 countries.
Trial summary
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with either paclitaxel and carboplatin (with or without bevacizumab) or pemetrexed and cisplatin to patients with locally advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancers
- What is being tested?
- GDC-0980, bevacizumab and carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2011to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy
- Adequate hematologic and end organ function
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of the study
- Measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors), with the exception of prostate cancer (two rising PSA Levels that meet the criteria of progression per PSA Working Group) and ovarian cancer (two rising CA-125 levels greater than the ULN)
Who cannot join
- Current dyspnea at rest due to complications of advanced malignancy, or other conditions requiring continuous supplemental oxygen
- Uncontrolled hypomagnesemia or hypokalemia
- History of Grade >= 3 fasting hyperglycemia
- Any condition requiring full-dose anticoagulants
- Known HIV infection
- Known untreated or active central nervous system (CNS) metastases
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- Pregnancy, lactation, or breastfeeding
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
- For Arm B: Conditions that preclude the use of bevacizumab
- For Arm C: Conditions that preclude the use of pemetrexed or cisplatin
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Study site
Boston, Massachusetts, 02114
Study site
Boston, Massachusetts, 02215
Study site
Los Angeles, California, 90025
Study site
Tampa, Florida, 33612
About this study
Official title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With Either Paclitaxel and Carboplatin (With or Without Bevacizumab) or Pemetrexed and Cisplatin in Patients With Solid Tumors
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with either paclitaxel and carboplatin (with or without bevacizumab) or pemetrexed and cisplatin to patients with locally advanced or metastatic solid tumors.
- Conditions
- Solid Cancers
- Being tested
- GDC-0980, bevacizumab, carboplatin, cisplatin, paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0980Drug
Oral escalating dose
bevacizumabDrug
Intravenous repeating dose
carboplatinDrug
Intravenous repeating dose
cisplatinDrug
intravenous repeating dose
paclitaxelDrug
Intravenous repeating dose
pemetrexedDrug
intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: GDC-0980; Drug: carboplatin; Drug: paclitaxel |
| B | Experimental | Not described Receives: Drug: GDC-0980; Drug: bevacizumab; Drug: carboplatin; Drug: paclitaxel |
| C | Experimental | Not described Receives: Drug: GDC-0980; Drug: cisplatin; Drug: pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first
Incidence of dose limiting toxicities (DLTs)
Measured: Up to 21 days from Last Patient In (LPI) in Stage 1 of study
Nature of adverse events
Measured: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first
Nature of dose limiting toxicities (DLTs)
Measured: Up to 21 days from Last Patient In (LPI) in Stage 1 of study
Severity of adverse events
Measured: Up to 30 days after last dose of study treatment
Secondary outcomes (4)
Total exposure
Measured: Up to 32 months or early study discontinuation
Maximum plasma concentration
Measured: Up to 32 months or early study discontinuation
Time to maximum observed plasma concentration
Measured: Up to 32 months or early study discontinuation
Plasma half-life
Measured: Up to 32 months or early study discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancersStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301716
- Sponsor's protocol ID
- PIM4946g
- Other IDs
- GO01336
- Status last verified
- Nov 2016
- First submitted
- 18 Feb 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With Either Paclitaxel and Carboplatin (With or Without Bevacizumab) or Pemetrexed and Cisplatin in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT01301716
- Acronym / sponsor ID
- PIM4946g
- Conditions
- Solid Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with either paclitaxel and carboplatin (with or without bevacizumab) or pemetrexed and cisplatin to patients with locally advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: GDC-0980, Drug: carboplatin, Drug: paclitaxel |
| B | Experimental | Drug: GDC-0980, Drug: bevacizumab, Drug: carboplatin, Drug: paclitaxel |
| C | Experimental | Drug: GDC-0980, Drug: cisplatin, Drug: pemetrexed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy
- Adequate hematologic and end organ function
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of the study
- Measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors), with the exception of prostate cancer (two rising PSA Levels that meet the criteria of progression per PSA Working Group) and ovarian cancer (two rising CA-125 levels greater than the ULN)
Key exclusion criteria (10 listed)
- Current dyspnea at rest due to complications of advanced malignancy, or other conditions requiring continuous supplemental oxygen
- Uncontrolled hypomagnesemia or hypokalemia
- History of Grade >= 3 fasting hyperglycemia
- Any condition requiring full-dose anticoagulants
- Known HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDC-0980Oral escalating dose | Drug | A, B, C |
| bevacizumabIntravenous repeating dose | Drug | B |
| carboplatinIntravenous repeating dose | Drug | A, B |
| cisplatinintravenous repeating dose | Drug | C |
| paclitaxelIntravenous repeating dose | Drug | A, B |
| pemetrexedintravenous repeating dose | Drug | C |
Primary outcome
Incidence of adverse events
Time frame: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first
Incidence of dose limiting toxicities (DLTs)
Time frame: Up to 21 days from Last Patient In (LPI) in Stage 1 of study
Nature of adverse events
Time frame: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first
Nature of dose limiting toxicities (DLTs)
Time frame: Up to 21 days from Last Patient In (LPI) in Stage 1 of study
Severity of adverse events
Time frame: Up to 30 days after last dose of study treatment
4 secondary outcomes
Total exposure
Time frame: Up to 32 months or early study discontinuation
Maximum plasma concentration
Time frame: Up to 32 months or early study discontinuation
Time to maximum observed plasma concentration
Time frame: Up to 32 months or early study discontinuation
Plasma half-life
Time frame: Up to 32 months or early study discontinuation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GDC-0980, bevacizumab and carboplatin in people with Solid Cancers, run by Genentech, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.